Product/Service

Clinical Services

Source: PAREXEL International

Parexel

In today’s pressure-filled biopharmaceutical development environment, no company can afford to spend the $800M or more it takes to bring a product from the lab to the marketplace, only to have it fail in critical Phase III clinical trials.

In today’s pressure-filled biopharmaceutical development environment, no company can afford to spend the $800M or more it takes to bring a product from the lab to the marketplace, only to have it fail in critical Phase III clinical trials. Yet nearly one-half of all products entering Phase III trials fail to reach the market.

How do you improve the chances of success for your products and avoid such costly mistakes? By working with an experienced clinical partner throughout the product development process – a partner with the global resources, and in-depth expertise to help you move your products through every phase of clinical development as quickly, smoothly, and cost-effectively as possible.

Pharmaceutical trial experience and expertise
PAREXEL is right where you need us as a full-service partner for your complete clinical trial research needs. Whatever your clinical trial requirements – from Phase I through Phase IV – we leverage our global facilities, therapeutic-area knowledge, advanced technology, and more than 25 years of experience to deliver proven clinical services for studies of any size, anywhere in the world. Our full range of services includes:

Pharmaceutical product development strategies/consulting

  • Clinical trial strategies
  • Study design
  • Regulatory strategies
  • Pricing/reimbursement strategies

 

Early phase clinical trials – Phase I/IIa

  • Dedicated early-phase clinics and labs
  • Clinical pharmacology
  • Bioequivalence/bioavailability studies
  • Pharmacodynamics/pharmacokinetics
  • Pre-screened volunteer and patient populations
  • Broad therapeutic area expertise
  • First-in-Human studies
  • Proof of Concept studies
  • Ethnobridging

 

Pivotal trials – Phase IIb/III

  • Protocol design
  • Investigator/site recruitment
  • Patient recruiting
  • Technology implementation
  • Trial/site management
  • Database design
  • Data analysis/biostatistics
  • Medical writing services

 

Peri-approval/post-marketing studies – Phase IIIb/IV

  • Risk management programs
  • Pharmacovigilance studies/reporting
  • Patient registries
  • Observational studies
  • Health economics studies

 

Advanced eClinical technologies

  • EDC
  • CTMS
  • IVRS/IWRS
  • Web portals
  • ePRO

 

With PAREXEL as your clinical trial research partner, you can accelerate time to market, reduce development costs, and minimize the risk of delays and trial failure – benefits that give your products an advantage in the marketplace at a time when even a small competitive edge can deliver significant returns.